Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Robot-assisted surgery.
- Кому может быть актуально
- Состояния в реестре: Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer, Hepatectomy. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Clinical Trial to Evaluate the Efficacy and Safety of Endoscopy System for General Surgery, Gynecology and Thoracic Surgery
Обзор
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.
Подробное описание
The trial was designed using a prospective, multi-centre, single-group target value approach.
For subjects who intend to undergo general surgery, gynaecological surgery and thoracic surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.
To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.
Вмешательства
- Процедура Robot-assisted surgery
Surgery with the Cornerstone Surgical Robot.
Первичные конечные точки
- Surgical non-referral rate [Срок оценки: during the surgery]
Вторичные конечные точки (4)
- The surgeon's operating time [Срок оценки: during the surgery]
- Length of postoperative stay [Срок оценки: up to 12 weeks]
- Intraoperative blood loss [Срок оценки: during the surgery]
- Length of stay [Срок оценки: The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.]
Критерии участия
Критерии включения
- Age ≥ 18 and ≤ 80 years;
- Body Mass Height Index (BMI) 18<BMI<30kg/㎡;
- Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery;
- Written informed consent.
Критерии исключения
- Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
- With other malignancies or a previous history of other malignancies.
- Preoperative imaging suggests that the tumour has distant metastases.
- The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
- Severe bleeding tendencies or coagulopathic disorders.
- With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
- Women who are pregnant or nursing an infant.
- With severe allergies and suspected or established alcohol, drug or substance addiction.
- Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Ханчжоу
Публикации
- Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4. PMID 25670040
- Somashekhar SP, Deshpande AY, Ashwin KR, Gangasani R, Kumar R, Shetty S. Comparative Evaluation of the Short-Term Treatment Outcomes Between Open, Laparoscopic- and Robotic-Assisted Surgical Approaches for Rectal Cancer Treatment. Indian J Surg Oncol. 2020 Dec;11(4):649-652. doi: 10.1007/s13193-020-01137-z. Epub 2020 Jul 10. PMID 33299282
Идентификаторы
NCT: NCT06587152 · F-00359-002